{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T08:06:10Z","timestamp":1779782770506,"version":"3.53.1"},"reference-count":31,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T00:00:00Z","timestamp":1769731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T00:00:00Z","timestamp":1769731200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,6]]},"abstract":"\n Aims<\/jats:title>\n \n The study's aim is to evaluate the pharmacokinetics (PK) and safety of leritrelvir, a novel 3\u2010chymotrypsin\u2010like cysteine protease (3CLpro) inhibitor, in patients with severe renal impairment (RI;\n n<\/jats:italic>\n \u2009=\u20097) compared to healthy controls (\n n\u2009=<\/jats:italic>\n \u00a08).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This nonrandomized, open\u2010label, parallel\u2010group, single\u2010dose trial included primary PK endpoints (\n C<\/jats:italic>\n \n max<\/jats:italic>\n <\/jats:sub>\n , AUC\n 0\u2010t<\/jats:sub>\n , AUC\n 0\u2010\u221e<\/jats:sub>\n , t\n 1\/2<\/jats:sub>\n ) and safety endpoints (AEs, vital signs, laboratory tests). Log\u2010transformed PK parameters were analysed by ANOVA to calculate GMRs (90% confidence intervals [CIs]) for group comparisons, with statistical significance assessed for exposure differences.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n PK analysis revealed similar median time\u2010to\u2010peak concentration (\n T<\/jats:italic>\n \n max<\/jats:italic>\n <\/jats:sub>\n ) but a reduced elimination half\u2010life (t\n 1\/2<\/jats:sub>\n ) in the RI group (4.20\u2009h\n vs<\/jats:italic>\n . 5.09\u2009h). The geometric mean ratios (90% CI) of systemic exposure parameters indicated increases of 30.34% for\n C<\/jats:italic>\n \n max<\/jats:italic>\n <\/jats:sub>\n , 54.19% for AUC\n 0\u2010t<\/jats:sub>\n , and 56.83% for AUC\n 0\u2010\u221e<\/jats:sub>\n in the RI group compared to controls.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Modest PK alterations in severe renal impairment are clinically insignificant given leritrelvir's wide therapeutic index. The drug is well\u2010tolerated (mild\u2010to\u2010moderate, short\u2010duration AEs), and no dose adjustment is needed for patients with renal impairment.<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/bcp.70474","type":"journal-article","created":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T01:14:49Z","timestamp":1769822089000},"page":"1886-1893","source":"Crossref","is-referenced-by-count":0,"title":["Tolerability and pharmacokinetics of leritrelvir in Chinese participants with severe renal impairment and healthy matched control subjects"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-9004-1264","authenticated-orcid":false,"given":"Zi\u2010yi","family":"Zhou","sequence":"first","affiliation":[{"name":"Drug Clinical Trial Institution The First Affiliated Hospital of Xiamen University Xiamen China"},{"name":"School of Basic Medicine and Clinical Pharmacy China Pharmaceutical University Nanjing 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